Senior Program Manager

Job Category:

Research and Development

QMS Impact Category: Direct

 

Position Summary

ASP is looking for a Senior Program Manager who thrives on complexity and impact. In this role, reporting to the PMO Director, you will be accountable for leading multiple cross‑functional teams and driving execution across high‑visibility, complex programs with minimal oversight. You will lead critical medical device development programs across sterilization, washing and disinfection, and consumables translating innovative ideas into compliant, market‑ready solutions that protect patients and advance healthcare.

Location:  US Remote position (preferred in PST or MST) to support development team in CA time zone

What Success Looks Like:

• Complex programs delivered predictably through major development and commercialization milestones 
• Cross‑functional teams aligned, risks surfaced early, and decisions made with clarity and speed 
• Strong trust and credibility with functional and senior leaders

 

Duties and Responsibilities

• Lead Complex Medical Device Programs: Lead high‑impact medical device development programs across hardware, systems, and consumables from concept through commercialization, ensuring delivery against business, customer, and regulatory expectations.
• Drive Cross‑Functional Execution: Align and lead cross‑functional teams across Engineering, Quality, Regulatory, Operations, Marketing, and external partners to deliver integrated program outcomes on time and to standard.
• Strengthen Planning & Execution Rigor: Develop and continuously refine integrated program plans, proactively managing scope, schedule, resources, dependencies, and critical path to improve predictability and accelerate key milestones.
• Own Program Risk & Issue Management: Proactively identify, assess, and mitigate program risks, prioritizing actions based on business impact and ensuring timely escalation and resolution to protect delivery, quality, and compliance.
• Enable Effective Decision‑Making: Facilitate structured, data‑driven problem solving for complex technical and organizational challenges, enabling timely decisions and rapid course correction while preventing recurrence.
• Ensure Strategic & Regulatory Alignment: Own alignment of programs with evolving business priorities, customer needs, and applicable medical device regulatory and quality system requirements throughout the product lifecycle.
• Drive Stakeholder Alignment & Executive Communication: Own executive‑level communication, influence cross‑functional alignment, resolve trade‑offs, and maintain momentum across complex, multi‑team programs.
• Foster Collaboration & Continuous Improvement: Promote a collaborative, high‑performance environment that encourages innovation, continuous improvement, and shared accountability across program teams.
• Mentor & Model Senior Program Leadership: Serve as a role model for program management excellence by sharing best practices, mentoring peers, and raising execution standards across the organization.

 

Other Duties:

☐N/A

Performs other duties assigned as needed

 

Qualifications

Education:

 High School or Equivalent

 Associate’s Degree

 Bachelor’s Degree

 Master’s Degree

 PhD Degree

Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline required.

Preferred Advanced degree (Master’s Degree)

 

Years of Related Experience:

• 6+ years of program management experience leading end-to-end product development and commercialization of regulated products.
• 4+ years in the Medical Device industry, including hands-on experience leading programs that resulted in FDA 510(k) clearance, with working knowledge of 21 CFR 820 and ISO 13485.
• Demonstrated ability to lead lar